PALLIHIP-study: Spinal Phenol IN Glycerol (SPING-block) in palliative, frail, older adults with a hip fracture: a study protocol

PALLIHIP研究:脊髓酚甘油(SPING阻断)治疗髋部骨折的姑息治疗、体弱老年患者:一项研究方案

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Abstract

BACKGROUND: In the Netherlands, approximately 20,000 older adults sustain a hip fracture every year. Most of these patients are frail, institutionalised, have limited postoperative mobility and a high mortality rate. When surgery is not feasible or preferred, optimizing quality of life and effective pain management becomes paramount. However, current analgesic strategies often fail to provide sustained relief and timely discharge. Timely discharge is essential to prevent hospital-related complications in frail patients. The Spinal Phenol IN Glycerol (SPING) block, a novel intrathecal neurolytic technique adapted from spinal anaesthesia, has been developed as an innovative approach for palliative pain treatment in this patient population. The PALLIHIP study aims to evaluate the effects of the SPING block on pain and quality of life in frail, institutionalised older adults with hip fractures. METHODS: PALLIHIP is a prospective multicentre cohort study that will be conducted in 19 Dutch hospitals. PALLIHIP will aim to enroll 210 patients. The primary objective is to evaluate the impact on pain and quality of life, assessed at admission, 24 h, one week, six weeks, and three months after treatment with SPING. Secondary outcomes include complications, mobility level, care dependency, caregiver burden, quality of dying, survival, and patient and caregiver satisfaction. Patient characteristics associated with treatment success will be explored. Healthcare and societal costs will be estimated through activity-based costing and a budget impact model. Semi-structured interviews and focus groups with patients, informal caregivers, and healthcare professionals will explore experiences, preferences, and implementation barriers. Ultimately, the goal is to establish a framework with a standardised protocol for effective, consistent application of the SPING block in clinical practice. DISCUSSION: This study will deliver the first prospective data on clinical effectiveness, patient-centred outcomes, and economic impact of the SPING block in frail, older adults with hip fractures. We hypothesise that the SPING block provides rapid, sustained analgesia with reduced opioid requirements, facilitates early discharge, and improves patient-centered outcomes. Findings may be able to provide evidence to inform future national guideline development and support the development of a standardised protocol for nonoperative palliative fracture care in frail, institutionalised older adults with a hip fracture. TRIAL REGISTRATION: Clinical trial number: not applicable. The PALLIHIP study is an observational cohort study on palliative fracture care in frail older adults with a hip fracture and was deemed exempt from the Medical Research Involving Human Subjects Act (WMO) by the Medical Ethics Committee of Amphia Hospital (protocol number NW2024-049).

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